A comparison of physiology-based interpretation of the fetal heart rate patterns during labour at term to guideline-based interpretation in the prediction of neonatal and labour outcomes

ISRCTN	ISRCTN59827903
DOI	https://doi.org/10.1186/ISRCTN59827903
Sponsor	University of Ferrara
Funder	Investigator initiated and funded

Submission date: 20/12/2025
Registration date: 14/01/2026
Last edited: 12/01/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Austin Ugwumadu
Principal investigator, Public, Scientific

Department of Obstetrics & Gynaecology , St George’s University Hospital, Blackshaw Road
London
SW17 0QTT
United Kingdom

Phone	+44 7956174222
Email	austin.ugwumadu@stgeorges.nhs.uk

Dr Gianluca Straface
Principal investigator, Scientific, Public

Policlinico Abano Terme, Piazza Cristoforo Colombo 1
Abano Terme
35031
Italy

Phone	+39 3382813207
Email	gstraface@casacura.it

Study information

Primary study design	Observational
Observational study design	Cohort study
Participant information sheet	48709_PIS (Italian).pdf
Scientific title	Physiology-based versus guideline-based interpretation of intrapartum cardiotocograph in nulliparous women in term labour at baseline and longitudinally in the prediction of early neonatal outcome: a prospective observational study with randomisation of interpretation methods
Study acronym	PHYSGUIDE
Study objectives	The study compares Physiology-based CTG interpretation to Guidelines-based CTG interpretation in the prediction of a composite adverse perinatal outcome including; 5-minute Apgar score <7, neonatal acidosis defined as pH <7.05 and base excess <-12mmol/l, antenatal brain injury, admission to neonatal intensive care unit (NICU), neonatal encephalopathy, need for therapeutic cooling, neonatal sepsis, meconium aspiration syndrome, hypoglycaemia, feto-maternal haemorrhage, perinatal stroke, intrapartum or neonatal death <28 days. A secondary aim is to compare the incidence of emergency Caesarean section and instrumental vaginal delivery between the two methods of CTG interpretation.
Ethics approval(s)	Approved 08/07/2025, Comitato Etico Territoriale Area Centro-EST Veneto (Comitato Etico Territoriale, Area Centro-Est Veneto, Azienda Ospedale Università Padova,Via Giustiniani 1, Padova, 35128, Italy; +39 498212341; ce.sperimentazione@aopd.veneto.it), ref: 6259/AT/25
Health condition(s) or problem(s) studied	Fetal heart rate patterns during labour at term
Intervention	This is a prospective observational study of Physiology-based interpretation of intrapartum CTG compared to Guidelines-based interpretation in the prediction of early neonatal outcome. Following enrolment, the site study coordinator informs the statistician and sends him the anonymised intrapartum CTG trace for assignment of a study number and randomisation to either Group A (Guideline-based interpretation/scoring first) or Group B (Physiology-based interpretation/scoring performed first). The site study coordinator enters the maternal characteristics, labour, and neonatal outcomes into the study database, which is overseen by the statistician. The statistician sends the randomised and anonymised CTG to the scorers who are blinded to the maternal characteristics, labour, and neonatal outcomes, for interpretation/scoring using standardised Physiology-based and Guideline-based tools. The timing of the (alternative) interpretation of the same CTG is randomly allocated to either 15 weeks or 20 weeks after the first interpretation, with a different but linked number also blinded to the scorers, so that no CTG can be identified by the scorers or interpreted/scored using both methods within 3 months of the first scoring. The women and babies are monitored with continuous CTG as clinically indicated and managed according to the local clinical protocols and practice. The maternal demographics, labour characteristics, and neonatal outcomes entered into the study database by the centre study coordinator is reviewed by the statistician for consistency and accuracy of data entry. The scorers send the CTG scores to the statistician for entry into the study database and subsequent analyses of perinatal and neonatal outcomes at baseline 0 - 2 hours, and longitudinally 2 - 8 hours, and 1 hour before birth.
Intervention type	Other
Primary outcome measure(s)	The primary outcome is a composite of adverse perinatal outcomes, including: 5-minute Apgar score, neonatal acidosis defined as pH <-12mmol/l, admission to neonatal intensive care unit (NICU), incidence of neonatal encephalopathy, need for therapeutic cooling, meconium aspiration syndrome, persistent hypoglycaemia, perinatal stroke (MRI diagnosis), feto-maternal haemorrhage (low haemoglobin), or intrapartum or neonatal death measured using a review of patient notes at one time point
Key secondary outcome measure(s)	Incidence of emergency Caesarean section and instrumental vaginal delivery measured using a review of patient notes at one time point
Completion date	18/11/2028

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Female
Target sample size at registration	2500
Key inclusion criteria	1. Primigravid/Nulliparous women admitted in term labour (defined as uterine contractions frequency of 1 or more in 10 minutes and/or cervical dilatation >/=3cm after 37 completed weeks of gestation) 2. Managed with continuous CTG monitoring 3. Consent to participate in the study
Key exclusion criteria	1. Parous women 2. Women with non-cephalic fetal presentation 3. Fetal abnormality 4. Multiple pregnancy 5. Antenatal CTG recording (defined as no uterine contractions and no cervical dilatation) 6. Abnormal CTG recording (without uterine contractions or cervical dilatation >/=3cm)
Date of first enrolment	18/11/2025
Date of final enrolment	17/11/2028

Locations

Countries of recruitment

Italy

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			12/01/2026	No	Yes

Additional files

48709_PIS (Italian).pdf: Participant information sheet

Editorial Notes

22/12/2025: Trial's existence confirmed by Comitato Etico Territoriale Area Centro-EST Veneto.